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The purpose of this study is to develop preliminary evidence, such as effect size and variance estimates, to guide successful conduct of a properly-powered clinical trial to assess the benefit of a mitochondrial cocktail (incorporating individualization of treatment) in Gulf War illness (GWI).
See below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator |
| |
| Arm 2 | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized mitochondrial cocktail | Dietary Supplement | Nutrient cocktail comprising: thiamine, nicotinamide, pantothenic acid, riboflavin, L-carnitine, alpha lipoic acid, CoQ10, vitamin C, vitamin E, and omega 3 fatty acids (Cod Liver Oil). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in single item General Self-Rated Health Visual Analog Scale from baseline | 0, 3, 6 months (double-blind phase) | |
| Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises | 6 months (double-blind phase) | |
| Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo | 0, 3, 6 months (double-blind phase) | |
| Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo | 6 months (double-blind phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index) | Secondary measures will incorporate assessment of summed symptom score (sum of ratings for UCSD GWI symptom index) at primary endpoint time point. We will assess at additional time points (9, 12 month) and will assess effects stratified by sex; by dominant ethnicity; and by use of medications that can affect levels or disposition of supplement components (e.g. statin use). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | La Jolla | California | 92093 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 17, 2022 | Mar 31, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018923 | Persian Gulf Syndrome |
| D028361 | Mitochondrial Diseases |
| ID | Term |
|---|---|
| D009784 | Occupational Diseases |
| D000067398 | War-Related Injuries |
| D014947 | Wounds and Injuries |
| D008659 | Metabolic Diseases |
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Parallel Design study is followed by Crossover to open label treatment.
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| Placebo | Dietary Supplement | 6 months for the double-blind phase |
|
| 6, 9, 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |